Brain Swelling During Dialysis

University of Aarhus12 enrolled

Overview

The proposed controlled, randomized study aims to compare pre-dilution hemodiafiltration (HDF) and low flux hemodialysis (HD) regarding acute changes in the brain. The study consist of two examination days placed one week apart. 12 HD patients will be recruited to the study. The patients will be randomly placed in two groups: Pre-dilution hemodiafiltration during the first examination and low flux hemodialysis during the second day or vice versa. Brain Magnetic Resonance Imaging (MRI) will be obtained before and after both treatments. The MRI-data will later be processed to estimate brain volume changes during the two types of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease

Interventions

HDF during the first examinationPROCEDURE

The patient will receive treatment with pre-dilution hemodiafiltration during the first examination. During the second examination the patient will receive treatment with low flux hemodialysis. MRI of the brain will be performed before and after the treatment. The MRI-data will later be processed to determine the degree of brain volume change due to the treatment.

HD during the first examinationPROCEDURE

The patient will receive treatment with low flux hemodialysis during the first examination. During the second examination the patient will receive treatment with pre-dilution hemodiafiltration. MRI of the brain will be performed before and after the treatment. The MRI-data will later be processed to determine the degree of brain volume change due to the treatment.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Informed consent * Patient with end-stage renal disease (ESRD) * Stabile hemodialysis treatment (Kt/V ≥ 1.3) * No contraindications against MRI (pacemaker or other metal implants, claustrophobia, severe adiposity) * Weight \<140kg Exclusion Criteria: * Clinical signs of new structural, thromboembolic or vascular brain disease the last 3 month before entering the study * Changes in corticosteroid treatment during the last two weeks * Change in diuretics during the last two weeks * Non-compliant with regard to salt and fluid intake * Acute disease

Locations (2)

Department of Renal Medicine C, Aarhus University Hospital, Skejby

Aarhus N, Denmark

The MR-Research Centre, Aarhus University Hospital, Skejby

Aarhus N, Denmark

Outcomes

Primary Outcomes

Percent Brain Volume Change (PBVC)

Brain volume before and after one hemodialysis session (4,5 hours) and one session of hemodiafiltration (4,5 hours). Dialysis sessions are performed one week apart. Randomization determines the order of treatment (hemodialysis vs hemodiafiltration). MRI-data will later be processed to estimate the PBVC.

Time frame: Brain volume before and after one hemodialysis session (4,5 hours) and one session of hemodiafiltration (4,5 hours). Dialysis sessions are performed one week apart.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.